Prescription Information for the Patient

IKERVIS 1 mg/ml Eye Drop Solution

ciclosporina (ciclosporin)

Read this entire prescription carefully before starting to use this medication, as it contains important information for you.

• Keep this prescription, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prescription. See section 4.

IKERVIS contains the active ingredient, cyclosporin. Cyclosporin is part of a group of medicines called immunosuppressants, which are used to reduce inflammation.

IKERVIS is used to treat adults with severe keratitis (inflammation of the cornea, the transparent layer at the front of the eye). It is used in patients with xerophthalmia (dry eye disease) who have not improved despite treatment with artificial tears.

You should consult a doctor if it worsens or does not improve.

You should attend your doctor's consultation at least every 6 months so that they can evaluate the effect of IKERVIS.

DO NOT use IKERVIS:

• if you are allergic to cyclosporine or any of the other ingredients in this medication (listed in section 6);
• if you have had or have cancer in or around the eye;
• if you have an eye infection.

Warnings and precautions

Use IKERVIS only as eye drops for the/your eye(s).

Consult your doctor or pharmacist before starting to use IKERVIS:

• if you have had a previous eye infection caused by the herpes virus that may have damaged the transparent front part of the eye (cornea);
• if you are taking any medication that contains steroids;
• if you are taking any medication to treat glaucoma.

Wearing contact lenses may increase the damage to the transparent front part of the eye (cornea). Therefore, remove your contact lenses before going to bed, before using IKERVIS; you can put them back on when you wake up.

Children and adolescents

Do not use IKERVIS in children and adolescents under 18 years old.

Other medications and IKERVIS

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Consult your doctor if you are using an eye drop that contains steroids along with IKERVIS, as these may increase the risk of adverse effects.

Use the IKERVIS eye dropat least 15 minutesafter using any other eye drop.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not useIKERVIS if you are pregnant.

If you can become pregnant, you must use contraception while using this medication.

It is likely that there will be very small amounts of IKERVIS in breast milk. If you are breastfeeding, consult your doctor before using this medication.

Driving and operating machinery

You may have blurred vision immediately after using the IKERVIS eye drop. In that case, wait until your vision is clear before driving or operating machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Recommended doseis one drop in the affected eye(s), once a day at bedtime.

Usage instructions

Follow these instructions carefully and consult your doctor or pharmacist if you do not understand anything.

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• Wash your hands.

• If you are wearing contact lenses, remove them at bedtime, before using the eye drops; you can put them back on when you wake up.
• Open the aluminum foil packet, which contains 5 single-use vials.

• Take one single-use vial from the aluminum foil packet and.

• Before using it, gently shake the single-use vial.

• Turn the cap to open it(image 1).

• Lower the lower eyelid with the help of a finger(image 2).

• Tilt your head back and look up.

• Gently press to release one drop of medication into the eye. Make sure not to touch the eye with the tip of the single-use vial.
• Blow your eyes several times to ensure the medication covers the eye.

• After using IKERVIS, press the corner of the eye near the nose with a finger and close your eyes gently for 2 minutes(image 3). This helps IKERVIS not pass to other parts of the body.

• If you use the eye drops in both eyes, repeat these steps in the other eye.

• Dispose of the single-use vial as soon as you have used it, even if there is still some liquid left in it.

• You must keep the remaining single-use vials in the aluminum foil packet.

If the drop falls outside the eye, try again.

If you use more IKERVIS than you should, wash your eye with water. Do not apply more drops until it is time for the next dose.

If you forget to use IKERVIS, continue with the next scheduled dose.Do not apply a double dose to compensate for missed doses. Do not use more than one drop per day in the affected eye(s).

If you interrupt treatment with IKERVISwithout consulting your doctor, the inflammation of the transparent front part of the eye (known as keratitis) will not be controlled and could cause visual impairment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects have been observed:

The most frequent adverse effects occur around the eyes.

Very frequent (may affect more than 1 in 10 people)

Pain when applying the drops to the eye.

Frequent (may affect up to 1 in 10 people)

Irritation, redness, and increased tearing when applying the drops to the eye, redness of the eyelid, watery eyes, red eye, blurred vision. Swelling of the eyelid, redness of the conjunctiva (thin membrane covering the front of the eye), eye irritation, eye pain.

Rare (may affect up to 1 in 100 people)

Rare eye-related adverse effects:

Discomfort, itching, or irritation in or around the eye, including the sensation of having something in it. Irritation or swelling of the conjunctiva (thin membrane covering the front of the eye), eye allergy, altered tear production, eye discharge, inflammation of the iris (colored part of the eye) or eyelid, deposits in the eye, bacterial infection or inflammation of the cornea (front transparent part of the eye), abrasion on the outer layer of the cornea, white spots on the cornea, cyst on the eyelid, itching of the eyelid, painful skin rash around the eye caused by the herpes zoster virus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the outer box, aluminum blister pack, and single-dose containers after «CAD». The expiration date is the last day of the month indicated.

Do not freeze.

After opening the aluminum blister packs, the single-dose containers should be kept in them to protect them from light and prevent evaporation. Discard immediately after use any opened single-dose container with remaining emulsion.

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of IKERVIS

• The active ingredient is cyclosporin. One millilitre of IKERVIS contains 1 mg of cyclosporin.
• The other components are medium-chain triglycerides, cetalkonium chloride, glycerol, tiloxapol, poloxamer 188, sodium hydroxide (to adjust the pH) and water for injection preparations.

Appearance of the product and contents of the pack

IKERVIS is a white milky eye drop emulsion.

It is supplied in single-dose containers made of low-density polyethylene (PEBD).

Each single-dose container contains 0.3 ml of eye drop emulsion.

The single-dose containers are packed in a sealed aluminium pouch.

Pack sizes: 30 and 90 single-dose containers.

Only some pack sizes may be marketed.

Marketing authorisation holder

SANTEN Oy

Niittyhaankatu 20

33720 Tampere

Finland

Responsible for manufacturing

EXCELVISION

Rue de la Lombardière

ZI la Lombardière

F-07100 Annonay

France

SANTEN Oy

Niittyhaankatu 20

33720 Tampere

Finland

You can obtain further information about this medicinal product by contacting the local representative of the marketing authorisation holder:

België/Belgique/BelgienLietuva

Santen OySanten Oy

Tel: +32 (0) 24019172Tel: +370 37 366628

????????Luxemburg/Luxemburg

Santen OySanten Oy

Tel: +359 (0) 888 755 393Tel: +352 (0) 27862006

Ceská republikaMagyarország

Santen OySanten Oy

Tel: +420 234 102 170Tel.: +36 (06) 16777305

DanmarkMalta

SantenPharma ABSanten Oy

Tel: +45 78737843Tel: +358(0) 3 284 8111

DeutschlandNederland

Santen GmbHSanten Oy

Tel: +49 (0) 3030809610Tel: +31 (0) 207139206

EestiNorge

Santen OySantenPharma AB

Tel: +372 5067559Tlf: +47 21939612

ΕλλάδαÖsterreich

Santen OySanten Oy

Tel: +358 (0) 3 284 8111Tel: +43 (0) 720116199

EspañaPolska

Santen Pharmaceutical Spain S.L.Santen Oy

Tel: +34 914 142 485Tel.: +48 (0) 221168608

FrancePortugal

SantenSanten Oy

Tel: +33 (0) 1 70 75 26 84Tel: +351 308 805 912

HrvatskaRomânia

Santen OySanten Oy

Tel: +358 (0) 3 284 8111Tel: +40 (0) 316300603

IrelandSlovenija

Santen OySanten Oy

Tel: +353 (0) 16950008Tel: +358 (0) 3 284 8111

ÍslandSlovenská republika

Santen OySanten Oy

Tel: +358 (0) 3 284 8111Tel: +421 (01) 23 332 5519

ItaliaSuomi/Finland

Santen Italy S.r.l.Santen Oy

Tel: +39 0236009983Tel: +358 (0) 974790211

ΚύπροςSverige

Santen OySantenPharma AB

Tel: +358 (0) 3 284 8111Tel: +46 (0) 850598833

LatvijaUnited Kingdom

Santen OySanten UK Limited

Tel: +371 677 917 80Tel: +44 (0)845 075 4863

Fecha de la última revisión de este prospecto:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.